UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019061 |
|---|---|
| Receipt number | R000022040 |
| Scientific Title | Effect of a plant-based diet in inflammatory bowel disease |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2023/11/12 10:06:41 |
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Basic information
Public title
Effect of a plant-based diet in inflammatory bowel disease
Acronym
Plant-based diet in inflammatory bowel disease
Scientific Title
Effect of a plant-based diet in inflammatory bowel disease
Scientific Title:Acronym
Plant-based diet in inflammatory bowel disease
Region
| Japan |
Condition
Condition
inflammatory bowel disease: Crohn disease, ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of superiority of plant-based diet in the treatment of inflammatory bowel disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate at 6 weeks after commencement of therapy
Rate of maintenance of remission at 2, 5, 15, and 20 years after discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Semi-vegetarian diet (800-2000 kcal/day) during hospitalization (7-50 days)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients with Crohn disease or ulcerative colitis who take semi-vegetarian diet
Key exclusion criteria
Hospitalized patients with Crohn disease or ulcerative colitis who do not take semi-vegetarian diet
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuro |
| Middle name | |
| Last name | Chiba |
Organization
Akita City Hospital
Division name
Gastroenterology
Zip code
010-0933
Address
Akita
TEL
0188234171
mchiba@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kudo |
Organization
Akita City Hospital
Division name
General Administration Division
Zip code
010-0933
Address
4-30, Matsuoka-machi, Kawamoto, Akita city, Japan
TEL
018-823-4171(2114)
Homepage URL
ro-homn@city.akita.akita.jp
Sponsor or person
Institute
IBD Relapse Prevention Team
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Akita City Hospital
Address
4-30, Matsuoka-machi, Kawamoto
Tel
0188234171
ro-homn@city.akita.akita.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Efficacy of plant-based diet in inflammatory bowel disease
1) Chiba M et al. Lifestyle-related disease in Crohn disease: relapse prevention by a semi-vegetarian diet. World J Gastroenterol 2010;16:2484-95
2) Chiba M et al. Onset of ulcerative colitis during a low-carbohydrate weight-loss diet and treatment with a plant-based diet: a case report. Perm J 2016 Winter;20(1):80-84
3) Chiba M et al. Development and application of a plant-based diet scoring system for Japanese patients with inflammatory bowel disease. Perm J 2016 Fall;20 (4):62-68
4)Chiba M, et al. Induction with infliximab and plant-based diet as first-line (IPF) therapy in Crohn's disease: single-group trial. Perm J 2017;21:17-009
5) Chiba M, et al. How to avoid primary nonresponders to infliximab in Crohn`s disease. (Letter) Inflamm Bowel Dis 2017 Nov; 23(11): E55-E56
6) Chiba M, et al. Relapse prevention in ulcerative colitis by plant-based diet through educational hospitalization: a single-group trial. Perm J 2018;22:17-167
7) Chiba M, et al. Onset of ulcerative colitis in the second trimester after emesis gravidarum: treatment with plant-based diet. Inflamm Bowel Dis 2018;24:e8-e9 Letter
8) Chiba M, Nakane K, Komatsu M. Lifestyle medicine in inflammatory bowel disease. Perm J 2018;22:18-062 Letter
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2003 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2003 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2003 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022040
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/04/28 | Protocol PBD UMIN000019061.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
